Product Code: HTY FDA class 2 21 CFR 888.3040

Pin, Fixation, Smooth

Orthopedic

A smooth fixation pin is a thin, smooth metallic implant driven into bone to stabilize fractures, maintain bone alignment, or anchor other fixation hardware during orthopedic procedures. It is classified as an FDA Class 2 device under 21 CFR 888.3040, indicating moderate risk and requiring 510(k) premarket clearance. Product code HTY falls under the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

204

FEI Numbers

283

Registration Numbers

283

Unique Applicants

137

Years Active

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Basic Information

Product Code: HTY
Device Class: FDA class 2
Regulation Number: 888.3040
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 204 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253325	ZipToe Hammertoe Fusion System	Dec 29, 2025	Substantially Equivalent	Toetal Solutions
K252657	Impact PEEK Union Nail System	Sep 19, 2025	Substantially Equivalent	Nvision Biomedical Technologies, Inc.
K250315	RONAVIS FX (FX-001)	Aug 01, 2025	Substantially Equivalent	AIRS, Inc.
K251362	PediFlex Flexible Nail System	Jun 24, 2025	Substantially Equivalent	OrthoPediatrics Corp.
K250646	Impact PEEK Union Nail System	Jun 11, 2025	Substantially Equivalent	Nvision Biomedical Technologies
K241014	Biomet Kirschner Wires (K-Wires)	May 22, 2024	Substantially Equivalent	Biomet, Inc.
K231272	OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail	Dec 01, 2023	Substantially Equivalent	OSSIO , Ltd.
K231147	Hammerdesis Interphalangeal Fusion System	Sep 14, 2023	Substantially Equivalent	Intelivation
K230750	OSSIOfiber® Cannulated Trimmable Fixation Nail	Sep 13, 2023	Substantially Equivalent	OSSIO , Ltd.
K231905	Electro-Spec Steri-Caps	Aug 14, 2023	Substantially Equivalent	Electro-Spec, Inc.
K231339	Tyber Medical Pin and Wire System (various)	Jul 06, 2023	Substantially Equivalent	Tyber Medical, LLC
K221283	Hammertoe Truss System (HTS)	Sep 06, 2022	Substantially Equivalent	4Web Medical, Inc.
K220906	SECURE-LOCK	Jul 22, 2022	Substantially Equivalent	Xiros, Ltd.
K213982	Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires	Feb 17, 2022	Substantially Equivalent	Pacific Instruments
K211789	restor3d Pin Implants	Jan 04, 2022	Substantially Equivalent	Restor3D
K211439	Small Bone Nailing System	Sep 30, 2021	Substantially Equivalent	Skeletal Dynamics, Inc.
K203698	CoLink Sfx Implant System	May 04, 2021	Substantially Equivalent	In2bones USA, LLC
K203475	LimaCorporate Kirschner Wire	Feb 05, 2021	Substantially Equivalent	Lima Corporate S.P.A.
K201838	PediFlex Flexible Nail System	Jan 29, 2021	Substantially Equivalent	OrthoPediatrics Corp.
K203465	OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design	Jan 06, 2021	Substantially Equivalent	OSSIO , Ltd.
K202777	VeriFixx Small Bone Implant	Nov 17, 2020	Substantially Equivalent	Armis Biopharma, Inc.
K201803	OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant	Oct 16, 2020	Substantially Equivalent	OSSIO , Ltd.
K201715	Smart Toe II, X Fuse	Aug 05, 2020	Substantially Equivalent	Stryker GmbH
K200068	Arthrex DynaNite K-Wire	Jun 29, 2020	Substantially Equivalent	Arthrex, Inc.
K190652	OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant	Mar 06, 2020	Substantially Equivalent	OSSIO , Ltd.
K190926	Hammertoe Truss System (HTS)	Jul 23, 2019	Substantially Equivalent	4Web, Inc.
K190287	Arthrex DynaNite® PIP (Hammertoe) Implant	May 03, 2019	Substantially Equivalent	Arthrex, Inc.
K183228	HammerToe Compression System	Jan 25, 2019	Substantially Equivalent	Paragon 28, Inc.
K181180	OSSIO Pin Product Family	Jan 10, 2019	Substantially Equivalent	OSSIO , Ltd.
K180087	A.M. Surgical Intramedullary Fixation Device	May 18, 2018	Substantially Equivalent	A.M. Surgical, Inc.
K171715	HammerTube System	Mar 05, 2018	Substantially Equivalent	Paragon 28
K172485	Footmotion HammerToe	Mar 02, 2018	Substantially Equivalent	Newclip Technics
K173616	DIP Arthrodesis System	Jan 19, 2018	Substantially Equivalent	In2bones Sas
K173013	WishBone K-Wire System	Dec 14, 2017	Substantially Equivalent	Wishbone Medical, Inc.
K173051	Orthofix MJ-FLEX THE NEW METAIZEAU NAIL	Nov 16, 2017	Substantially Equivalent	Orthofix Srl
K170326	dynaMX Intramedullary Implant	Jul 20, 2017	Substantially Equivalent	Arthrex, Inc.
K170418	Stryker SonicPin System	Jun 20, 2017	Substantially Equivalent	Stryker Trauma GmbH
K163327	Precifit Medical Kirschner Wires	May 08, 2017	Substantially Equivalent	Precifit Medical, Ltd.
K161489	Syntorr K-wire and Pin System	Sep 16, 2016	Substantially Equivalent	Syntorr, Inc.
K160264	Additive Orthopaedics Hammertoe Correction System	Jun 01, 2016	Substantially Equivalent	Additive Orthopaedics, LLC
K160194	StarFuse Interphalangeal Pin	Apr 26, 2016	Substantially Equivalent	Phalanx Innovations
K152662	S-Wire	Mar 09, 2016	Substantially Equivalent	Spinal Resources, Inc.
K153204	In2Bones Kirschner wire	Feb 01, 2016	Substantially Equivalent	In2bones Sas
K152627	IFS Fixation Scaffold System	Jan 13, 2016	Substantially Equivalent	Metric Medical Devices, Inc.
K151876	Bio2 Fusion Implant System	Dec 30, 2015	Substantially Equivalent	Bio2 Technologies, Inc.
K142478	opti-Toe	May 29, 2015	Substantially Equivalent	Graham Medical Technologies, LLC (D.B.A.Gramedica)
K150626	Rush Medullary Pins	May 01, 2015	Substantially Equivalent	Zimmer, Inc.
K150416	ProCinch Adjustable Loop Device	Apr 17, 2015	Substantially Equivalent	Stryker Endoscopy
K143702	Arthrex Blunt Tip Screws with Fiber Tape	Apr 09, 2015	Substantially Equivalent	Arthrex, Inc.
K143049	LYNC intramedullary implant	Feb 19, 2015	Substantially Equivalent	Novastep
K143618	Kirschner Wires, Steinmann Pins	Feb 06, 2015	Substantially Equivalent	Zimmer, Inc.
K143063	Stryker SonicPin System, Stryker SonicAnchor System	Jan 27, 2015	Substantially Equivalent	Stryker Trauma GmbH
K141714	PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM	Oct 24, 2014	Substantially Equivalent	Wrightmedicaltechnologyinc
K142134	C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES	Sep 12, 2014	Substantially Equivalent	Conmed Corporation, Largo
K141004	INTRAOSSEOUS FIXATION SYSTEM	Aug 21, 2014	Substantially Equivalent	Orthohelix Surgical Designs, Inc.
K141577	ARTHREX PIP DART	Jul 18, 2014	Substantially Equivalent	Arthrex, Inc.
K133932	INION FREEDOMPIN	Apr 11, 2014	Substantially Equivalent	Inion OY
K133477	TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS	Feb 10, 2014	Substantially Equivalent	Synchro Medical
K133950	ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)	Jan 22, 2014	Substantially Equivalent	Bioretec, Ltd.
K133520	HAMMERLOCK 2	Jan 09, 2014	Substantially Equivalent	Biomedical Enterprises, Inc.
K132895	WMT IMPLANTABLE K-WIRE	Oct 23, 2013	Substantially Equivalent	Wrightmedicaltechnologyinc
K131640	SMOOTH OR THREADED METALLIC BONE FASTENER	Oct 16, 2013	Substantially Equivalent	Biomedical Ent., Inc.
K130105	RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM	May 17, 2013	Substantially Equivalent	Depuy Mitek, A Johnson & Johnson Company
K122415	X-FIX DYNAMIC EXTERNAL DISTRACTOR	Mar 15, 2013	Substantially Equivalent	Arex USA, LLC
K121008	TRILLIANT SURGICAL K-WIRES	Jun 04, 2012	Substantially Equivalent	Trilliant Surgical, Ltd.
K121004	APEX KIRSCHNER WIRES AND STEINMANN PINS	Apr 24, 2012	Substantially Equivalent	Apex Tools & Orthopedics Co.
K120165	INTRAOSSEOUS FIXATION SYSTEM	Apr 17, 2012	Substantially Equivalent	Orthohelix Surgical Designs, Inc.
K103623	NEWDEAL INTERPHALANGEAL IMPLANT	Mar 20, 2012	Substantially Equivalent	Newdeal Sas
K112990	ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE	Dec 19, 2011	Substantially Equivalent	Arthrex, Inc.
K112675	ARROW-LOK DIGITAL SYSTEM	Dec 12, 2011	Substantially Equivalent	Arrowhead Medical Device Technologies, LLC
K112197	MEMOMETAL INTRA-MEDULLARY BONE FASTENER	Nov 17, 2011	Substantially Equivalent	Memometal Technologies
K112254	APEX KIRSCHNER WIRES AND STEINMANN PINS	Oct 11, 2011	Substantially Equivalent	Apex Tools & Orthopedics Co.
K110123	PCL TIGHTROPE	Apr 28, 2011	Substantially Equivalent	Arthrex, Inc.
K110047	VERTICOR K-WIRE SYSTEM	Feb 28, 2011	Substantially Equivalent	Verticor, Ltd.
K101837	ACL TIGHTROPE DOUBLE BUNDLE	Dec 28, 2010	Substantially Equivalent	Arthrex, Inc.
K102215	KIRSCHNER WIRES, STEINMAN PINS	Nov 09, 2010	Substantially Equivalent	Evergreen Orthopedic Research Lab
K102072	MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)	Nov 03, 2010	Substantially Equivalent	Memometal Technologies
K100926	ARROWHEAD FIXATION DEVICE	Oct 29, 2010	Substantially Equivalent	Arrow Products, Inc.
K100736	KIRSCHNER AND GUIDE WIRES	Sep 10, 2010	Substantially Equivalent	Smt Schilling Metalltechnik GmbH
K094043	LIGAMENTOTAXOR	Aug 17, 2010	Substantially Equivalent	Arex USA
K100652	ACL TIGHTROPE	Jun 23, 2010	Substantially Equivalent	Arthrex, Inc.
K091955	STRYKER SONICPIN SYSTEM	Apr 02, 2010	Substantially Equivalent	Howmedica Osteonics Corp.
K091951	HAMMERLOCK	Feb 19, 2010	Substantially Equivalent	Biomedical Ent., Inc.
K092038	APTUS K-WIRE SYSTEM	Sep 23, 2009	Substantially Equivalent	Medartis AG
K083490	BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685	Mar 18, 2009	Substantially Equivalent	Biopro, Inc.
K082375	ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM	Oct 17, 2008	Substantially Equivalent	OrthoPediatrics Corp.
K082017	STARR FRAME STEINMANN PIN	Oct 10, 2008	Substantially Equivalent	Starr Frame, LLC
K080879	ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM	Jun 24, 2008	Substantially Equivalent	Bioretec, Ltd.
K081097	ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM	Jun 03, 2008	Substantially Equivalent	Orthopediatrics, LLC
K073311	OSTEOTRANS-OT PIN	May 13, 2008	Substantially Equivalent	Takiron Co., Ltd.
K073674	BONE FIXATION WIRE (KIRSCHNER WIRE)	Mar 24, 2008	Substantially Equivalent	Signal Medical Corp.
K071616	ARC SURGICAL BIOTRAK PIN SYSTEM	Dec 19, 2007	Substantially Equivalent	Arc Surgical, LLC
K071863	ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)	Aug 31, 2007	Substantially Equivalent	Bioretec, Ltd.
K070598	MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE	Jul 26, 2007	Substantially Equivalent	Memometal Technologies
K070555	ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES	Jul 13, 2007	Substantially Equivalent	Orthopro, LLC
K070561	KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES	May 25, 2007	Substantially Equivalent	Teleflex Medical
K063719	ARTHREX CROSSPIN, MODEL AR-1964P	Mar 06, 2007	Substantially Equivalent	Arthrex, Inc.
K061607	STORM OPERATING KIT, MODEL 1-10-0	Jul 18, 2006	Substantially Equivalent	Intelligent Orthopaedics, Ltd.
K061164	ACTIVAPIN	Jul 06, 2006	Substantially Equivalent	Bioretec, Ltd.
K060654	DSI PINS AND WIRES	Apr 28, 2006	Substantially Equivalent	Delta Surgical Instruments, Inc.
K060283	TRANSET SYSTEM	Feb 22, 2006	Substantially Equivalent	Bonutti Research, Inc.
K052736	ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT	Nov 03, 2005	Substantially Equivalent	Arthrex, Inc.
K051605	SBI K-WIRES	Aug 10, 2005	Substantially Equivalent	Small Bone Innovations, LLC
K050259	ARTHREX BIO-PIN	May 27, 2005	Substantially Equivalent	Arthrex, Inc.
K043339	REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG	Apr 18, 2005	Substantially Equivalent	Xtremi-T, LLC
K050275	MODIFICATION TO: INION OTPS BIODEGRADABLE PIN	Mar 07, 2005	Substantially Equivalent	Inion , Ltd.
K043106	PINN-ACL CROSSPIN	Jan 19, 2005	Substantially Equivalent	Linvatec Corp.
K041355	HUMERAL STAPLE	Jul 30, 2004	Substantially Equivalent	Smith & Nephew, Inc.
K041157	MODIFICATION TO SMALL BONE FIXATION SYSTEM	Jul 30, 2004	Substantially Equivalent	Hand Innovations, Inc.
K041288	MODIFICATION TO SMARTPIN	Jun 10, 2004	Substantially Equivalent	Linvatec Biomaterials, Inc.
K040500	ARTHROTEK LACTONAIL	May 25, 2004	Substantially Equivalent	Arthrotek, Inc.
K033717	TRANSET FRACTURE FIXATION SYSTEM	Feb 25, 2004	Substantially Equivalent	Bonutti Research, Inc.
K033968	HANSSON PIN SYSTEM	Feb 20, 2004	Substantially Equivalent	Howmedica Osteonics Corp.
K033406	SMALL BONE FIXATION SYSTEM	Jan 15, 2004	Substantially Equivalent	Hand Innovations, Inc.
K024185	BIODHOC	Jan 15, 2004	Substantially Equivalent	Future Medical Systems, SA
K032687	ACE NANCY NAIL	Oct 06, 2003	Substantially Equivalent	DePuy Orthopaedics, Inc.
K031712	INION OTPS BIODEGRADABLE PIN	Aug 28, 2003	Substantially Equivalent	Inion , Ltd.
K031083	OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500	Jun 12, 2003	Substantially Equivalent	Opus Medical, Inc.
K030665	BONE WIRE	Mar 25, 2003	Substantially Equivalent	Stork Instrumente GmbH
K022597	K-FIX	Nov 01, 2002	Substantially Equivalent	New Deal, S.A.
K022599	NEWDEAL K WIRE	Oct 30, 2002	Substantially Equivalent	New Deal, S.A.
K022531	2MM PEDIATRIC FLEX NAIL	Aug 26, 2002	Substantially Equivalent	Biomet, Inc.
K013888	FIXATION (STEINMANN) PINS	May 01, 2002	Substantially Equivalent	Miltex, Inc.
K014305	RESORBABLE LACTOSORB-L ACL CROSSPIN	Mar 29, 2002	Substantially Equivalent	Arthrotek, Inc.
K013781	RIDIDFIX 2.7MM BTB CROSS PIN KIT	Feb 06, 2002	Substantially Equivalent	Mitek Products
K013424	INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND	Dec 20, 2001	Substantially Equivalent	Hand Innovations, Inc.
K012125	OPUS MAGNUM ANCHOR & INSERTER	Sep 17, 2001	Substantially Equivalent	Opus Medical, Inc.
K012161	FLEX-NAILS	Aug 24, 2001	Substantially Equivalent	Fixano SA
K011522	RESORBABLE BONE PINS	Jul 31, 2001	Substantially Equivalent	Biomet, Inc.
K010983	PLLA PIN	Jun 13, 2001	Substantially Equivalent	Bionx Implants, Inc.
K010479	MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR	May 08, 2001	Substantially Equivalent	Bonutti Research, Inc.
K003527	MODIFICATION TO SYNTHES (USA) POLYPIN	Apr 09, 2001	Substantially Equivalent	Synthes (Usa)
K003659	PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260	Feb 20, 2001	Substantially Equivalent	Bionx Implants, Inc.
K002125	PINS AND WIRES	Oct 11, 2000	Substantially Equivalent	Implant Resource, Inc.
K991971	ARTHREX CHONDRAL DART, MODEL AR-4005B-18	Aug 04, 2000	Substantially Equivalent	Arthrex, Inc.
K994232	PHALANGEAL FIXATION SYSTEM	Mar 01, 2000	Substantially Equivalent	Medcanica, Inc.
K991064	METACARPAL FIXATION SYSTEM	Jun 23, 1999	Substantially Equivalent	Medcanica, Inc.
K990291	LACTOSORB BONE PIN	Mar 23, 1999	Substantially Equivalent	Biomet, Inc.
K983121	NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220	Oct 05, 1998	Substantially Equivalent	Syntec Scientific Corp.
K982719	THE BONE TIE	Sep 25, 1998	Substantially Equivalent	Surgicraft , Ltd.
K980854	RETROGRADE PEDIATRIC NAIL	Aug 11, 1998	Substantially Equivalent	Encore Orthopedics, Inc.
K974341	MITEK BTB ABSORBABLE (PLA) CROSS PIN	Apr 16, 1998	Substantially Equivalent	Mitek Products
K974291	MITEK BTB ABSORBABLE (PLA) CROSS PIN	Mar 05, 1998	Substantially Equivalent	Mitek Products
K973240	SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION	Nov 20, 1997	Substantially Equivalent	Synthes (Usa)
K971962	OSTEO KIRSCHNER WIRES	Aug 11, 1997	Substantially Equivalent	Osteonics Corp.
K971783	SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM	Jul 18, 1997	Substantially Equivalent	Synthes (Usa)
K971453	ORTHOTEC K-CAP SYSTEM	Jun 24, 1997	Substantially Equivalent	Orthotech
K961608	SYNTHES (U.S.A.) POLYPIN	May 09, 1997	Substantially Equivalent	Synthes (Usa)
K970733	SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM	Apr 02, 1997	Substantially Equivalent	Synthes (Usa)
K970036	FIXATION PIN OR ROD	Mar 25, 1997	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K970013	BIORIGID NAIL TIBIA	Mar 13, 1997	Substantially Equivalent	Aap GmbH and Co. Betriebs KG
K964500	ACUMED TENSION BAND PIN	Dec 09, 1996	Substantially Equivalent	Acu Med, Inc.
K964087	BLOCK STOP WIRES	Nov 25, 1996	Substantially Equivalent	Ferguson Medical
K963367	RMS K-WIRE	Oct 30, 1996	Substantially Equivalent	Rms Div.
K961522	KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN	Sep 23, 1996	Substantially Equivalent	Synvasive Technology, Inc.
K960642	NANCY NAIL	May 17, 1996	Substantially Equivalent	Landos, Inc.
K960483	STEINMAN PIN	Apr 09, 1996	Substantially Equivalent	American Medical Specialties, Inc.
K960482	K-WIRE	Apr 09, 1996	Substantially Equivalent	American Medical Specialties, Inc.
K960385	STERILE KIRSCHNER WIRES AND STEINMANN PINS	Mar 27, 1996	Substantially Equivalent	Depuy, Inc.
K955806	HOWMEDICA BIOABSORBABLE PIN	Feb 15, 1996	Substantially Equivalent	Howmedica, Inc.
K954543	GO UNIVERSALK-WIRE FLUTED DRILL	Dec 08, 1995	Substantially Equivalent for Some Indications	Genesis Orthopedics, Inc.
K953194	LACTOSORB BONE PIN	Oct 31, 1995	Substantially Equivalent for Some Indications	Biomet, Inc.
K954001	SPETZLER PIN	Oct 26, 1995	Substantially Equivalent	Howmedica Corp.
K943856	FIXATION PINS/WIRES	Jul 06, 1995	Substantially Equivalent	Acu Med, Inc.
K945639	SPETZLER PIN	Apr 14, 1995	Substantially Equivalent for Some Indications	Howmedica Corp.
K940673	J.B.S. SELF-TAPPING THREADED PIN	Nov 14, 1994	Substantially Equivalent	J.B.S., S.A.
K940669	J.B.S. B.A.C. PIN	Nov 14, 1994	Substantially Equivalent	J.B.S., S.A.
K940666	JBS SMOOTH FIXATION PIN	Nov 14, 1994	Substantially Equivalent	J.B.S., S.A.
K941434	K-WIRES AND STEINMANN PINS	Oct 03, 1994	Substantially Equivalent	Omega Surgical Instruments, Inc.
K925098	BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE	Jul 19, 1994	Substantially Equivalent for Some Indications	Bioscience, Inc.
K931836	ACUFEX SMOOTH AND THREADED PINS	Jun 28, 1994	Substantially Equivalent	Acufex Microsurgical, Inc.
K931697	FIXATION PIN	May 12, 1994	Substantially Equivalent	Orthologic Corp.
K930969	BAUMER PINS	Mar 29, 1994	Substantially Equivalent	Baumer Ortopedia , Ltd.
K932348	ORTHOPEDIC SMOOTH PIN FIXATION	Mar 01, 1994	Substantially Equivalent	Osteomed Corp.
K940109	TAVA K-WIRE	Feb 22, 1994	Substantially Equivalent	Tava Surgical Instruments
K922766	ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION	Jul 09, 1993	Unknown	Acufex Microsurgical, Inc.
K925301	OTI ORTHOPEDIC FASTENER SYSTEM	Mar 16, 1993	Substantially Equivalent	Osteo Technology, Inc.
K922194	OSTEO STEINMANN PIN	Jul 23, 1992	Substantially Equivalent	Osteo AG
K922193	OSTEO KIRSCHNER WIRE	Jul 23, 1992	Substantially Equivalent	Osteo AG
K911375	G-PIN	Sep 23, 1991	Substantially Equivalent	Dr.M.A.Galluzzo
K911505	FIXATION WIRE	Apr 12, 1991	Substantially Equivalent	Simpex, Inc.
K911452	FIXATION PIN	Apr 12, 1991	Substantially Equivalent	Simpex, Inc.
K905345	K-WIRE	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K905341	RUSH PIN	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K905337	STEINMAN PIN	Dec 11, 1990	Substantially Equivalent	O'Tec Corp.
K903265	STEINMAN PIN	Jul 30, 1990	Substantially Equivalent	Onyx Medical Corp.
K903264	K-WIRE	Jul 30, 1990	Substantially Equivalent	Onyx Medical Corp.
K901273	L.M.S. SELF-DETACHABLE BROACH WITH STOP	Jun 05, 1990	Substantially Equivalent	Med-Tek Corp.
K890902	BIOFIX* BIODEGRADABLE FIXATION ROD	Nov 03, 1989	Substantially Equivalent	Davis & Geck, Inc.
K895079	ACE BEADED K-WIRES ACE OLIVE WIRES	Sep 13, 1989	Substantially Equivalent	Buckman Co., Inc.
K874913	ORTHOMET PIN SYSTEM	Jan 07, 1988	Substantially Equivalent	Orthomet, Inc.
K872842	PIN, HIP, KNOWLES	Aug 07, 1987	Substantially Equivalent	Military Engineering, Inc.
K864912	PDS (POLYDIOXANON) ABSORBABLE PIN	Jul 09, 1987	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K863734	STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS	Oct 20, 1986	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K863119	CANNULATED LAG SCREWS	Sep 03, 1986	Substantially Equivalent	Downs Surgical , Ltd.
K860590	ACE UNILATERAL FIXATOR	Mar 07, 1986	Substantially Equivalent	Buckman Co., Inc.
K852563	PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONG	Jun 28, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852562	PIN SET, BONE, RUSH, 4 THRU 10 1/2 INCHES LONG	Jun 28, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852561	PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONG	Jun 28, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K852560	PINSET, BONE, RUSH 9-1/2 THRU 20-3/4 INCHES LONG	Jun 28, 1985	Substantially Equivalent	The Huxley Instrument Corp.
K850026	ORTHOPEDIC IMPLANT NAILS & PINS	May 20, 1985	Substantially Equivalent	Kirkstil Corp., Inc.
K833952	FIXATION PINS	Feb 10, 1984	Substantially Equivalent	ETHICON, Inc.
K831005	WIRE & STEINMAN PINS	May 18, 1983	Substantially Equivalent	Kirschner Medical Corp.
K771418	PIN RETRACTORS	Sep 22, 1977	Substantially Equivalent	Stryker Corp.